Many surgical procedures require the insertion of catheters and/or surgical devices into blood vessels and other anatomical structures. For example, in the treatment of vascular disease, it is often necessary to insert an instrument such as a catheter into a blood vessel to perform a treatment procedure. Such treatment procedures often involve piercing a wall of the blood vessel, inserting an introducer sheath into the blood vessel via the opening, and maneuvering the catheter through the introducer sheath to a target location within the blood vessel. Of course, once such a procedure is completed, the opening in the wall of the blood vessel must be sealed to prevent bleeding and to facilitate healing of the wound. The sealing of the puncture has commonly been accomplished by the application of direct pressure over the puncture site by a physician or other trained medical professional. However, this technique is time consuming and may lead to complications such as thrombosis, which may be dangerous to the patient.
Other sealing techniques include the application of a sealing member or plug of material (most often biogenic sealing material) over the opening in the blood vessel to seal the wound. However, proper placement of sealing members and plugs is difficult to achieve and materials left inside the body may pose serious health risks to the patient if, for example, the material enters the blood stream.
Another sealing technique that may be employed to prevent bleeding while facilitating healing of the wound is the use of a suture. Applicant's U.S. Pat. No. 6,451,031 (hereinafter “the '031 patent”), entitled “Blood Vessels Suturing Device With Single Guide-Wire/Needle Receiving Lumen”, which issued on Sep. 17, 2002, describes a device that employs a suture to seal a puncture in an anatomical structure. The '031 patent describes a device for sealing a tissue puncture including proximal and distal portions offset by a connecting member so that a needle may exit a lumen in the proximal portion through a needle insertion opening across a tissue receiving gap and enter through a needle receiving opening into a lumen in the distal portion. The distal lumen also has an opening for a guide wire. A method for sealing a tissue puncture by inserting a device such as that described above into the puncture via a guide wire, which is removed, so that the tissue is within the tissue receiving gap, and inserting a first suture needle distally from the proximal lumen, through the tissue, and into the distal lumen. The device is then rotated and a second suture needle similarly penetrates the tissue at a second location, and the device is withdrawn and the suture is tightened. The '031 patent is incorporated by reference herein as fully as if set forth in its entirety.
Applicant's U.S. Pat. No. 6,436,109 (hereinafter “the '109 patent”), entitled “Device and Method for Suturing Blood Vessels and the Like”, which issued on Aug. 20, 2002, and Applicant's U.S. Pat. No. 6,428,549 (hereinafter “the '549 patent”), entitled “Device and Method for Suturing Blood Vessels and the Like”, which issued on Aug. 6, 2002, describe devices for sealing a puncture in an anatomical structure comprising a proximal portion having a first needle lumen extending therethrough to a first needle opening. The '109 and '549 patents also states that the device includes a distal portion including a second needle opening facing the first needle opening across a tissue receiving gap and opening into a second needle lumen and a connecting portion coupled between the proximal and distal portions and offset from the proximal and distal portions to create the tissue receiving gap. According to the '109 and '549 patents, when the connecting portion is received within a puncture in an anatomical structure, a portion of the anatomical structure received within the tissue receiving gap is located on one side of a plane including a central axis of the puncture. The '109 and '549 patents are incorporated by reference herein as fully as if set forth in their entirety.
These patents have in common the use of several needles in connection with the process of sealing the puncture in an anatomical structure. However, each of the devices described in these patents requires that the needles be handled by a surgeon. The handling of needles by a surgeon during a surgical procedure may be problematic. The needles are thin and difficult to handle, particularly with regards to loading the needles into the small lumens through which the needles are maneuvered during the surgical procedure. Furthermore, blood or other anatomical substances may be present in the vicinity of the procedure, making it still more difficult for the surgeon to handle the needles.